Get Hhs Form Fda 3613 2015-2025

Filling out the HHS Form FDA 3613 can be a straightforward process with the right guidance. This form is essential for requesting export certificates related to products regulated by the Food and Drug Administration. This guide aims to help users navigate through each section of the form effectively.

Follow the steps to complete the HHS Form FDA 3613 online successfully.

1. Click the ‘Get Form’ button to access the HHS Form FDA 3613 online. This will open the form in your browser, allowing you to begin filling it out.
2. Enter your requestor information in Section 1, including your name, address, firm name, telephone number, fax number, and firm Tax ID code. Ensure all details are accurate for processing.
3. If applicable, provide the billing address in Section 2. If it is the same as your requestor information, you may skip this step.
4. In Section 3, enter your shipping account number or label. This is where mailing supplies can be sent along with your form.
5. Section 4 requires detailed manufacturer information. For each manufacturer involved, fill in the firm name, address (note that P.O. Boxes are not acceptable), registration number, license number, and date of the last FDA inspection.
6. In Section 5, provide distributor information if applicable, ensuring all firms listed have U.S. addresses.
7. Section 6 is for product information. Fill in the trade name, proper name, marketing status, product code if applicable, and other relevant details.
8. Indicate whether the product has ever been recalled in Section 7. If 'Yes', provide the recall number and close-out date.
9. In Section 8, list the countries for which the certificates are requested. You must list at least one country.
10. In Section 9, specify what product information should appear on the certificate.
11. Section 10 asks if the country destination should be listed on the certificate. Respond with 'Yes' or 'No' and indicate the total number of certificates requested.
12. Lastly, review your form for accuracy and completeness. Once satisfied, you can save changes, download the form, print it, or share it according to your needs.

Take action now to ensure your export requests are processed efficiently by completing the HHS Form FDA 3613 online.